BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent Graft, Infrapopliteal, Venous Arterialization

    PMA: P220025 · Supplement: S001 · Decision Oct 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stent Graft, Infrapopliteal, Venous Arterialization
    Trade Name
    LimFlow System
    PMA Number
    P220025
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    QWN
    Generic Name
    Stent graft, infrapopliteal, venous arterialization
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 12, 2023
    Date Received
    September 15, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220025.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QWN Stent Graft, Infrapopliteal, Venous Arterialization